FDA.reportPublic FDA data

Medline-Microtek

Primary DI
00748426144037
Brand
Medline-Microtek
Company
Microtek Medical LLC
Model
Organ Bag
Catalog number
ISO1003
Device description
Isolation Bag, 46 cm x 47 cm (18 in x 18.5 in)
Published
2025-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGYBag, Intestine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGYBag, IntestineGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10748426144034PackageGS110In Commercial Distribution
20748426144031PackageGS11In Commercial Distribution
00748426144037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1074842614403410748426144034
2074842614403120748426144031
00748426144037007484261440377484261440370748426144037

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative procedure bagA sterile flexible container used to temporarily isolate a patient body part/organ during a surgical procedure, typically to segregate it from the surgical site. The device may be used to: 1) cover a dirty body part (e.g., hand/foot) to prevent cross-contamination with the surgical site; 2) cover a clean body part (e.g., hand/foot) while performing surgery on another site (e.g., leg/knee); 3) retain organs during abdominal surgery; or 4) keep organs (e.g., intestines) moist during surgery. It is typically made of a soft, strong, clear plastic film with a seamless bottom and draw strings at the opening to create a seal around the chosen body part/organ. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
106908437
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00748426121861OLYMPUSEquipment DrapesOME-V2-D2026-05-28
00748426146802Medline-MicrotekFluid Warming - Warmer EquipmentEFW5L2026-05-20
00748426146925Medline-MicrotekSurgical Slush - Hush-Slush EquipmentORS-1075EU2026-05-20
00748426146932Medline-MicrotekSurgical Slush - Hush-Slush EquipmentORS-2038EU2026-05-20
00748426262076AQUABLATION THERAPY®Patient DrapesDR39002026-04-06
00748426264483Medline-MicrotekPatient Drapes5960UK2026-03-16
00748426264490Medline-MicrotekEquipment Drapes8033651EU2026-03-16
00748426264506Medline-MicrotekEquipment Drapes49652026-03-16
20748426264487Medline-MicrotekPatient Drapes5960UK2026-03-16
20748426264494Medline-MicrotekEquipment Drapes8033651EU2026-03-16
10748426264503Medline-MicrotekEquipment Drapes49652026-03-16
00748426264315Medline-MicrotekPatient Drapes59602026-02-11
00748426261543NA33206633202026-02-26
10748426261540NA33206633202026-02-26
10748426144294Medline-MicrotekEquipment Drapes5096NS2026-02-18
10748426144560Medline-MicrotekEquipment Drapes15427-002026-02-18
10748426144584Medline-MicrotekEquipment Drapes2904N2026-02-18
10748426144591Medline-MicrotekEquipment Drapes4604N2026-02-18
10748426144607Medline-MicrotekEquipment Drapes4650N2026-02-18
10748426144614Medline-MicrotekEquipment Drapes4954N2026-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
507073870711913M™ Steri-Drape™3M COMPANYKGY2026-04-17
10885632426605HALYARDOWENS & MINOR DISTRIBUTION, INC.KGY2026-02-05
20885632426602HALYARDOWENS & MINOR DISTRIBUTION, INC.KGY2026-02-05
20748426262599Medline-MicrotekMicrotek Medical LLCKGY2026-01-19
00748426262595Medline-MicrotekMicrotek Medical LLCKGY2026-01-19
00888937027891LapSacCoopersurgical, Inc.KGY2025-09-03
00888937027907LapSacCoopersurgical, Inc.KGY2025-09-03
00888937027914LapSacCoopersurgical, Inc.KGY2025-09-03
00888937027884LapSacCoopersurgical, Inc.KGY2025-09-03
20888937027895LapSacCoopersurgical, Inc.KGY2025-09-03
20888937027901LapSacCoopersurgical, Inc.KGY2025-09-03
20888937027918LapSacCoopersurgical, Inc.KGY2025-09-03
10748426144034Medline-MicrotekMicrotek Medical LLCKGY2025-07-28
10192253067873CONVERTORSCardinal Health 200, LLCKGY2025-06-30
50192253067871CONVERTORSCardinal Health 200, LLCKGY2025-06-30
16931918131153AllesetGRI Medical & Electronic Technology Co., Ltd.KGY2025-06-20
06931918131156AllesetGRI Medical & Electronic Technology Co., Ltd.KGY2025-06-20
00748426123568Cardinal HealthMicrotek Medical LLCKGY2024-09-26
30748426123569Cardinal HealthMicrotek Medical Inc.KGY2024-09-26
16931918199078AllesetGRI Medical & Electronic Technology Co., Ltd.KGY2023-07-20
26931918199075AllesetGRI Medical & Electronic Technology Co., Ltd.KGY2023-07-20
G026085001P&P Medical Surgical LLCP&P Medical Surgical LLCKGY2022-02-11
G026086001P&P Medical Surgical LLCP&P Medical Surgical LLCKGY2022-02-11
G026087001P&P Medical Surgical LLCP&P Medical Surgical LLCKGY2022-02-11
G026088001P&P Medical Surgical LLCP&P Medical Surgical LLCKGY2022-02-11
00749756253956DeRoyalDEROYAL INDUSTRIES, INC.KGY2021-06-30
50749756253951DeRoyalDEROYAL INDUSTRIES, INC.KGY2021-06-30
00827002156562LapSacCOOK INCORPORATEDKGY2020-10-02
00827002157361LapSacCOOK INCORPORATEDKGY2020-10-02
00827002157378LapSacCOOK INCORPORATEDKGY2020-10-02